FDA.reportPublic FDA data

MMM guaifenesin solution

Manufacturer
Southern Sales & Services, Inc.
Effective date
2021-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:54

Label at a glance#

ProductMMM guaifenesin solution
Active ingredientGUAIFENESIN
Label structure11 sections

Storage and handling

Store at room temperature 15º-30ºC (59º-86ºF) Tamper-Evident: Do not use if seal under cap is torn, broken or missing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 tespoonful) contains:

Guaifenesin USP 100mg

OTC - PURPOSE SECTION

Expectorant
SUGAR FREE / ALCOHOL

OTC - DO NOT USE SECTION

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless directed by a doctor.

WARNINGS SECTION

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm(mucus) unless directed by a doctor.

Stop use and ask a doctor if

cough persists for more than1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.


Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

OTC - STOP USE SECTION

Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

DOSAGE & ADMINISTRATION SECTION

Do not take more than 6 doses in any 24 hours period

Adults and children 12 years and over - 10 to 20ml (2 to 4 teaspoonfuls every 4 hours or as directed by doctor)

children under 12 years - do not use

STORAGE AND HANDLING SECTION

Store at room temperature 15º-30ºC (59º-86ºF)

Tamper-Evident: Do not use if seal under cap is torn, broken or missing.

INACTIVE INGREDIENT SECTION

Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potasium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD &C Red # 40 ,caramel color,purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

MMM - guaifenesin solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MMM ExpectorantMMM Expectorant

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN2
310604guaifenesin 20 MG/ML Oral SolutionSCD2
310604guaifenesin 100 MG per 5 ML Oral SolutionSY2
310604guaifenesin 100 MG per 5 ML Oral SyrupSY2
310604guaifenesin 200 MG per 10 ML Oral SolutionSY2
310604guaifenesin 300 MG per 15 ML Oral SolutionSY2
310604guaifenesin 400 MG per 20 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-020-202023-01-30C16284748780-1f386c649-a33b-0266-e053-dadaa90a7c1aMMM - Guaifenesin Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-020-20MMM guaifenesin solution118 mL in 1 BOTTLESOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-020MMM GUAIFENESIN SOLUTION (GUAIFENESIN) SOLUTION [SOUTHERN SALES & SERVICES, INC.]2Legacy NDC, 1 package rows20211115_c3413e54-489a-036f-e053-2995a90a8087.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-02069822-020-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM CITRATE1Q73Q2JULRIACT
MENTHOLL7T10EIP3AIACT
GUAIFENESIN495W7451VQACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d0b3c104-eb74-9132-e053-2995a90af6c6c3413e54-489a-036f-e053-2995a90a80872021-11-13WarningsExact identifier
spl id: d0b3c104-eb74-9132-e053-2995a90af6c6
spl set id: c3413e54-489a-036f-e053-2995a90a8087

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.